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  • P-ISSN 2233-4203
  • E-ISSN 2093-8950

Facile and Rapid Glycosylation Monitoring of Therapeutic Antibodies Through Intact Protein Analysis

Mass Spectrometry Letters / Mass Spectrometry Letters, (P)2233-4203; (E)2093-8950
2021, v.12 no.3, pp.85-92
Oh Myung Jin (Chungnam National University)
Seo Nari (Chungnam National University)
Seo JungA (Chungnam National University)
Kim Ga Hyeon (Chungnam National University)
An Hyun Joo (Chungnam National University)
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The therapeutic antibody drug market has experienced explosive growth as mAbs become the main therapeutic modality for a variety of diseases. Characterization of glycosylation that directly affects the efficacy and safety of therapeutic monoclonal antibodies (mAbs) is critical for therapeutics development, bioprocess system optimization, lot release, and compa-rability evaluation. The LC/MS approach has been widely used to structurally characterize mAbs, and recently attempts have been made to obtain comprehensive information on the primary structure and post-translational modifications (PTMs) of mAbs through intact protein analysis. In this study, we performed state-of-the-art LC/MS based intact protein analysis to readily iden-tify and characterize glycoforms of various mAbs. Different glycoforms of mAbs produced in different expression cell lines includ- ing CHO, SP2/0 and HEK cells were monitored and compared. In addition, the comparability of protein molecular weight, glycoform pattern, and relative abundances of glycoforms between the commercialized trastuzumab biosimilar and the original product was determined in detail using the given platform. Intact mAb analysis allowed us to gain insight into the overall mAb structure, including the complexity and diversity of glycosylation. Furthermore, our analytical platform with high reproducibility is expected to be widely used for biopharmaceutical characterization required at all stages of drug development and manufacturing.

intact protein, glycoform monitoring, mass spectrometry, bioterapeutics

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Mass Spectrometry Letters